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Anna Angelousi 1st Department of Internal Medicine, Unit of Endocrinology, Laikon Hospital, Athens, Greece

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Ploutarchos Tzoulis Department of Metabolism & Experimental Therapeutics, Division of Medicine, University College London, London, UK

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Marina Tsoli 1st Department of Propaedeutic and Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece

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Eleftherios Chatzellis 251 HAF and VA Hospital, Athens, Greece

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Anna Koumarianou Fourth Department of Internal Medicine, Hematology Oncology Unit, Attikon University Hospital, National and Kapodistrian University of Athens, Greece

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Gregory Kaltsas 1st Department of Propaedeutic and Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece

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Immunotherapy has revolutionised the treatment of oncological patients, but its application in various endocrine tumours is rather limited and is mainly used when conventional therapies have failed. Immune checkpoint inhibitors (ICIs) have been employed in progressive adrenocortical carcinoma, primarily utilizing the anti-PD-L1 agent pembrolizumab, obtaining overall response rates ranging between 14% and 23%. In contrast, the response rate in phaeochromocytoma/paraganglioma was substantially less at 9%, considering the small number of patients treated. Similarly, the response rate in advanced differentiated thyroid carcinomas treated with pembrolizumab was also low at 9%, although the combination of ICIs with tyrosine kinase inhibitors showed higher efficacy. Low response rates to ICIs have also been observed in progressive medullary thyroid cancer, except in tumours with a high mutation burden (TMB). Pembrolizumab or spartalizumab can be utilized in patients with high TMB anaplastic thyroid cancer, obtaining better response rates, particularly in patients with high PD-L1 expression. Immunotherapy has also been used in a few cases of parathyroid carcinoma, showing limited antitumour effect. Pituitary carcinomas may exhibit a more favourable response to ICIs compared to aggressive pituitary tumours, particularly corticotroph tumours. Patients with advanced neuroendocrine tumours achieve an overall response rate of 15%, which varies according to the primary tumour site of origin, degree of differentiation, and therapeutic regimen utilised. Future research is needed to evaluate the potential role of immunohistochemical biomarkers, such as programmed death 1/programmed death ligand 1 and TMB, as predictors for the response to immunotherapy. Furthermore, randomised prospective studies could provide more robust data on the efficacy and side effects of ICIs.

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Anna Koumarianou Medical Oncology Unit, Endocrine Unit, MRI Unit, Pathology Department, Fourth Department of Surgery, Medical Oncology Unit, Second Department of Internal Medicine Propaedeutic, Attikon University General Hospital, Rimini 1, 12462 Athens, Greece

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Stavroula Antoniou Medical Oncology Unit, Endocrine Unit, MRI Unit, Pathology Department, Fourth Department of Surgery, Medical Oncology Unit, Second Department of Internal Medicine Propaedeutic, Attikon University General Hospital, Rimini 1, 12462 Athens, Greece

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George Kanakis Medical Oncology Unit, Endocrine Unit, MRI Unit, Pathology Department, Fourth Department of Surgery, Medical Oncology Unit, Second Department of Internal Medicine Propaedeutic, Attikon University General Hospital, Rimini 1, 12462 Athens, Greece

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Nikolaos Economopoulos Medical Oncology Unit, Endocrine Unit, MRI Unit, Pathology Department, Fourth Department of Surgery, Medical Oncology Unit, Second Department of Internal Medicine Propaedeutic, Attikon University General Hospital, Rimini 1, 12462 Athens, Greece

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Dimitra Rontogianni Medical Oncology Unit, Endocrine Unit, MRI Unit, Pathology Department, Fourth Department of Surgery, Medical Oncology Unit, Second Department of Internal Medicine Propaedeutic, Attikon University General Hospital, Rimini 1, 12462 Athens, Greece

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Anastasios Ntavatzikos Medical Oncology Unit, Endocrine Unit, MRI Unit, Pathology Department, Fourth Department of Surgery, Medical Oncology Unit, Second Department of Internal Medicine Propaedeutic, Attikon University General Hospital, Rimini 1, 12462 Athens, Greece

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Nikolaos Tsavaris Medical Oncology Unit, Endocrine Unit, MRI Unit, Pathology Department, Fourth Department of Surgery, Medical Oncology Unit, Second Department of Internal Medicine Propaedeutic, Attikon University General Hospital, Rimini 1, 12462 Athens, Greece

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Dimitrios Pectasides Medical Oncology Unit, Endocrine Unit, MRI Unit, Pathology Department, Fourth Department of Surgery, Medical Oncology Unit, Second Department of Internal Medicine Propaedeutic, Attikon University General Hospital, Rimini 1, 12462 Athens, Greece

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George Dimitriadis Medical Oncology Unit, Endocrine Unit, MRI Unit, Pathology Department, Fourth Department of Surgery, Medical Oncology Unit, Second Department of Internal Medicine Propaedeutic, Attikon University General Hospital, Rimini 1, 12462 Athens, Greece

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Gregory Kaltsas Medical Oncology Unit, Endocrine Unit, MRI Unit, Pathology Department, Fourth Department of Surgery, Medical Oncology Unit, Second Department of Internal Medicine Propaedeutic, Attikon University General Hospital, Rimini 1, 12462 Athens, Greece

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Nicola Fazio Division of gastrointestinal medical oncology and neuroendocrine tumors, European Institute of Oncology (IEO) IRCCS, Milan, Italy

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Lorenzo Gervaso Division of gastrointestinal medical oncology and neuroendocrine tumors, European Institute of Oncology (IEO) IRCCS, Milan, Italy
Molecular Medicine Program, University of Pavia, Pavia, Italy

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Thorvardur R Halfdanarson Division of Medical Oncology Mayo Clinic, Rochester, Minnesota, USA

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Mohamad Sonbol Department of Hematology and Oncology, Mayo Clinic, Phoenix, Arizona, USA

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Rachel A Eiring Division of Medical Oncology Mayo Clinic, Rochester, Minnesota, USA

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Sara Pusceddu Division of Medical Oncology, National Cancer Institute, Milan, Italy

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Natalie Prinzi Division of Medical Oncology, National Cancer Institute, Milan, Italy

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Benedetta Lombardi Stocchetti Division of Medical Oncology, National Cancer Institute, Milan, Italy

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Simona Grozinsky-Glasberg Neuroendocrine Tumor Unit, ENETS Center of Excellence, Department of Endocrinology and Metabolism, Hadassah Medical Center and Faculty of Medicine, The Hebrew University, Jerusalem, Israel

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David J Gross Neuroendocrine Tumor Unit, ENETS Center of Excellence, Department of Endocrinology and Metabolism, Hadassah Medical Center and Faculty of Medicine, The Hebrew University, Jerusalem, Israel

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Thomas Walter Medical Oncology Department, Hopital Edourad Herriot, Hospices civils de Lyon, Lyon, France

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Patrick Robelin Medical Oncology Department, Hopital Edourad Herriot, Hospices civils de Lyon, Lyon, France

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Catherine Lombard-Bohas Medical Oncology Department, Hopital Edourad Herriot, Hospices civils de Lyon, Lyon, France

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Samuele Frassoni Department of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy

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Vincenzo Bagnardi Department of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy

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Lorenzo Antonuzzo Clinical Oncology Unit, Careggi University Hospital, Florence, Italy
Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy

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Clotilde Sparano Endocrinology Unit, Department of Experimental and Clinical Biomedical Sciences ’Mario Serio’, University of Florence, Florence, Italy

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Sara Massironi Division of Gastroenterology, and Center for Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, University of Milano-Bicocca School of Medicine, Monza, Italy

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Fabio Gelsomino Division of Oncology. Department of Hematology and Oncology, University Hospital of Modena, Modena, Italy

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Alberto Bongiovanni Oncologia medica, IRCCS Istituto Romagnolo per lo Studio dei Tumori ’Dino Amadori’, IRST S.r.l., Meldola, Italy

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Nicoletta Ranallo Oncologia medica, IRCCS Istituto Romagnolo per lo Studio dei Tumori ’Dino Amadori’, IRST S.r.l., Meldola, Italy

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Salvatore Tafuto Oncologia Sarcomi e Tumori rari, I.R.C.C.S. Ist. Naz. Tumori di Napoli ’G. Pascale’, Napoli, Italy

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Maura Rossi Oncology Unit and Centro Documentazione Osteonecrosi, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

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Mauro Cives Department of Interdisciplinary Medicine, University of Bari ’Aldo Moro’, Bari, Italy

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Ibrahim Rasul Kakil National Cancer Care and Research, Hamad Medical Corporation, Doha, Qatar

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Hytam Hamid Department of Surgery, Al-Moalem Medical City, Khartoum, Sudan

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Alessandra Chirco UO Oncologia Medica ASST Papa Giovanni XXIII, Bergamo, Italy

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Michela Squadroni Oncologia medica, Humanitas Gavazzeni Bergamo, Bergamo, Italy

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Anna La Salvia Medical Oncology Department, Hospital Universitario Doce de Octubre, Imas12, UCM, Madrid, Spain

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Jorge Hernando Vall Hebron University Hospital and Vall Hebron Institute of Oncology (VHIO), Barcelona, Spain

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Johannes Hofland Department of Internal Medicine, Sector Endocrinology, Rotterdam, the Netherlands

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Anna Koumarianou Hematology-Oncology Unit, Fourth Department of Internal Medicine, Attikon Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece

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Sabrina Boselli Data Management-Clinical Trial Office. Scientific Direction. European Institute of Oncology (IEO) IRCCS, Milan, Italy

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Darina Tamayo Data Management-Clinical Trial Office. Scientific Direction. European Institute of Oncology (IEO) IRCCS, Milan, Italy

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Cristina Mazzon Data Management-Clinical Trial Office. Scientific Direction. European Institute of Oncology (IEO) IRCCS, Milan, Italy

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Manila Rubino Division of gastrointestinal medical oncology and neuroendocrine tumors, European Institute of Oncology (IEO) IRCCS, Milan, Italy

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Francesca Spada Division of gastrointestinal medical oncology and neuroendocrine tumors, European Institute of Oncology (IEO) IRCCS, Milan, Italy

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We conducted a retrospective/prospective worldwide study on patients with neuroendocrine neoplasms (NENs) and a molecularly proven SARS-CoV-2 positivity. Preliminary results regarding 85 patients of the INTENSIVE study have been published in 2021. Now we are reporting the 2-year analysis.Here, we are reporting data from consecutive patients enrolled between 1 June 2020, and 31 May 2022. Among the 118 contacted centers, 25 were active to enroll and 19 actively recruiting at the time of data cut-off for a total of 280 patients enrolled. SARS-CoV-2 positivity occurred in 47.5% of patients in 2020, 35.1% in 2021, and 17.4% in 2022. The median age for COVID-19 diagnosis was 60 years. Well-differentiated tumors, non-functioning, metastatic stage, and gastroenteropancreatic (GEP) primary sites represented most of the NENs. COVID-19-related pneumonia occurred in 22.8% of the total, with 61.3% of them requiring hospitalization; 11 patients (3.9%) needed sub-intensive or intensive care unit therapies and 14 patients died (5%), in 11 cases (3.9%) directly related to COVID-19. Diabetes mellitus and age at COVID-19 diagnosis > 70 years were significantly associated with COVID-19 mortality, whereas thoracic primary site with COVID-19 morbidity. A significant decrease in both hospitalization and pneumonia occurred in 2022 vs 2020. In our largest series of NEN patients with COVID-19, the NEN population is similar to the general population of patients with NEN regardless of COVID-19. However, older age, non-GEP primary sites and diabetes mellitus should be carefully considered for increased COVID-19 morbidity and mortality. Relevant information could be derived by integrating our results with NENs patients included in other cancer patients with COVID-19 registries.

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